Label: DR.JART CICAPAIR TIGER GRASS CAMO DROPS- zinc oxide, titanium dioxide cream

  • NDC Code(s): 49404-142-01, 49404-142-02
  • Packager: Have & Be Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 21, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Titanium Dioxide 4.28%

    Zinc Oxide 2.88%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

    If used as directed with other sun protection meausres (see Directions), decreases the risk of skin cancer and early skin aging casued by the sun

  • DOSAGE & ADMINISTRATION

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: 

    – Limit time in the sun, especially from 10 am - 2 pm

    – Wear long-sleeved shirts, pants, hats and
    sunglasses

    • Children under 6 months: Ask a doctor

  • WARNINGS

    For external use only.
    Do not use on damaged or broken skin.
    When using this product, keep out of eyes. Rinse with water to remove.
    Stop using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    WATER
    CYCLOPENTASILOXANE
    ISONONYL ISONONANOATE
    METHYL TRIMETHICONE
    BUTYLOCTYL SALICYLATE
    PENTAERYTHRITYL TETRAISOSTEARATE
    DIPHENYLSILOXY PHENYL TRIMETHICONE
    DIPROPYLENE GLYCOL
    ISODODECANE
    LAURYL PEG-10TRIS(TRIMETHYLSILOXY)SILYLETHYLDIMETHICONE
    METHYL METHACRYLATE CROSSPOLYMER
    ACRYLATES/DIMETHICONE COPOLYMER
    NIACINAMIDE
    DISTEARDIMONIUM HECTORITE
    POLYMETHYLSILSESQUIOXANE
    MAGNESIUM SULFATE
    POLYGLYCERYL-4 ISOSTEARATE
    IRON OXIDES(CI 77492)
    DIPENTAERYTHRITYLHEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE
    BEESWAX
    1,2-HEXANEDIOL
    TRIETHOXYCAPRYLYLSILANE
    CENTELLA ASIATICA EXTRACT
    IRON OXIDES(CI 77491)
    CAPRYLYL GLYCOL
    SYNTHETIC FLUORPHLOGOPITE
    GLYCERYL CAPRYLATE
    CHROMIUM OXIDE GREENS
    ZEIN
    ETHYLHEXYLGLYCERIN
    SILICA DIMETHYL SILYLATE
    ALUMINUM HYDROXIDE
    LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL
    ADENOSINE
    ZEA MAYS (CORN) STARCH
    CITRUS PARADISI (GRAPEFRUIT) PEEL OIL
    HYDROGENATED LECITHIN
    ROSMARINUS OFFICINALIS (ROSEMARY) LEAFOIL
    CAPRYLIC/CAPRIC TRIGLYCERIDE
    HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL

  • OTHER SAFETY INFORMATION

    Protect the product in this container from excessive heat and direct sunlight

    You may report a serious adverse event from use of this product to: Report Reaction, LLC PO Box 22 Plainsboro, NJ 08536-0222

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DR.JART CICAPAIR TIGER GRASS CAMO DROPS 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49404-142
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.284 mg  in 30 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.864 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ISODODECANE (UNII: A8289P68Y2)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    CHROMIC OXIDE (UNII: X5Z09SU859)  
    ZEIN (UNII: 80N308T1NN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49404-142-021 in 1 CARTON05/15/2019
    1NDC:49404-142-0130 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/15/2019
    Labeler - Have & Be Co., Ltd. (690400408)
    Registrant - Have & Be Co., Ltd. (690400408)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(49404-142)